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NCT03604406 · ClinicalTrials.gov registry record · Phase 2
The Immunogenicity and Safety of Zostavax® and Shingrix® in Rheumatoid Arthritis Patients Using Abatacept
A Phase 2 study of Rheumatoid Arthritis and Herpes Zoster, sponsored by Kevin Winthrop.
- Active
- Registry status
- Phase 2
- Development phase
- 154
- Enrollment target
- 5
- Study locations
NCT03604406: Active Phase 2 study of Rheumatoid Arthritis and Herpes Zoster, sponsored by Kevin Winthrop.
NCT03604406 is a Phase 2 study of Rheumatoid Arthritis and Herpes Zoster that is active but no longer recruiting, run by Kevin Winthrop. The registered enrollment target is 154 participants, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (97% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03604406, a Phase 2 study of Rheumatoid Arthritis and Herpes Zoster, is active but no longer recruiting, sponsored by Kevin Winthrop.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 154 participants
- Enrollment target
- 5
- Study locations
Study Summary
This investigator-initiated study will serve as a sub-study for the American College of Rheumatology-sponsored VERVE protocol currently funded by the NIH. This double-blinded multicenter randomized pragmatic trial is designed to determine whether Zostavax or Shingrix are safe and effective in patients with rheumatoid arthritis (RA) currently using anti-tumor necrosis factor (TNF) therapies. Inclusion/exclusion criteria for this sub-study mirror that of the parent VERVE trial with the exception of abatacept therapy being allowed. Preliminary data from the VERVE parent protocol enrolling patients using anti-TNF therapy is encouraging in that few patients experienced adverse events (56 adverse events in 50 participants, out of 140 participants in total) and that 96.2% of these adverse events were considered either mild or moderate. Importantly, there have been no instances of vaccine dissemination or zoster events to date.
Primary Outcome
Surrogate measures of vaccine efficacy will be performed on all patients using samples collected at baseline prior to vaccination, and subsequently at 6 weeks, and one year post vaccination. These measures will include: a. Frequency of VZV-specific T cells as measured by interferon-gamma ELISPOT assay. Changes in these outcome measures will be evaluated using geometric means and percentage increases in geometric means of (a) VZV-specific reactive lymphocytes.
Conditions Studied
Interventions
- BIOLOGICAL Varicella Zoster Vaccine
- OTHER Placebo Injection
Study Locations (5)
Idaho
- St. Luke's Health System - Boise
Minnesota
- St. Paul Rheumatology - Eagan
New Mexico
- Jayashree Sinha, MD - Clovis
Oregon
- Oregon Health & Science University - Portland
Tennessee
- Arthritis Associates - Hixson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 154 participants |
| Start Date | 2014-05-08 |
| Est. Completion | 2026-02 |
| Phase | Phase 2 |
What the registry record for NCT03604406 still lists
NCT03604406 is an interventional study that assigns participants to a tested intervention. The registered 154 participants enrollment target is mid-sized for trials with a published cap, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (97% lower).
The record links to 3 conditions, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 2 interventions - of which Varicella Zoster Vaccine is the first listed.
NCT03604406 lists 5 locations in 5 states (Idaho, Minnesota, New Mexico).
Frequently Asked Questions
What is clinical trial NCT03604406 about?
NCT03604406 is a clinical study titled "The Immunogenicity and Safety of Zostavax® and Shingrix® in Rheumatoid Arthritis Patients Using Abatacept". This investigator-initiated study will serve as a sub-study for the American College of Rheumatology-sponsored VERVE protocol currently funded by the NIH. This double-blinded multicenter randomized pragmatic trial is designed to determine whether Zostavax or Shingrix are safe and effective in patien...
What is the current status of trial NCT03604406?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 154 participants. The study started on 2014-05-08. Estimated completion is 2026-02.
What conditions does trial NCT03604406 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis, Herpes Zoster, Inflammatory Disease.
What interventions are being tested in trial NCT03604406?
The interventions under investigation include: Varicella Zoster Vaccine (BIOLOGICAL), Placebo Injection (OTHER).
Who is sponsoring clinical trial NCT03604406?
This trial is sponsored by Kevin Winthrop, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03604406 being conducted?
This trial has 5 study locations across Idaho, Minnesota, New Mexico, Oregon, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03604406's enrollment target sits among peer trials
154 99th of 197 higher than 99 of 197 other Rheumatoid Arthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rheumatoid Arthritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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